Medical device companies in the us

European Regulatory Language Requirements

Sustaining competitive advantage within the				- LatvianLithuania - LithuanianMalta
medical device industry involves a global				- English & MaltesePoland -
product strategy that recognizes the European				PolishRomania - RomanianSlovakia -
market's substantial global market share.				SlovakSlovenia - SlovenianTurkey
Estimated at 30% of the global medical device				- TurkishEU Member State Official Languages
market, the European community poses
increasing regulatory challenges for medical				Depending on the extent of the product's
device manufacturers. Regulations controlling				presence in the European Union, there are
the manufacturing, marketing and usage of				currently up to 12 languages required for the
medical devices in the EU are forcing				labeling, IFUs, documentation, and marketing
manufacturers to incorporate language				materials in accordance with the IVDD and MDD
translation and localization into global				necessary for CE mark as displayed in TABLE I
development strategies as individual Member				.As the EU continues to grow and the trading
States demand product information in the				barriers dissolve, prospective Member States
language of the local user.An exigent				are actively transitioning regulations to
regulatory hurdle facing the medical device				meet the CE mark criteria, requiring new
industry is the European Union's IVDD 98/79				languages. A midday regulatory shadow to the
EC directive which went into effect December				EU, European Free Trade Association (EFTA)
7, 2003. Formulated five years ago, the IVDD				countries of Iceland, Liechtenstein and
98/79/EC dictates that as of the December				Norway are aggressively enforcing the CE
date, all new in vitro medical devices must				mark, shown in TABLE II . Although not a
bear CE Marks or face refusal into the				member of the EFTA, Switzerland is also
European market or regulatory, criminal or				enforcing medical device CE mark.In addition
product/civil liability.What is the guiding				to the EFTA, 13 more countries have applied
principle behind the new directive?The IVDD				for membership in the European Union.
Directive virtually eliminates the costly				Performing a parallel migration to the
regulations imposed by individual member				European Union's regulatory requirements,
states. Manufacturers who comply with the				several of these future Member States are
Directive will be able to apply the CE mark				actively adopting the CE Mark to ensure goods
to their products and market them freely				can freely move throughout the European
within member states of the EU.				Union, including Poland, Romania, Slovakia,
				and Turkey, seeTABLE III .
The IVDD (In Vitro Diagnostic Devices
Directive) is one of three associated				Global Harmonization and International
directives issued by the European Union,				Quality Standards
which together cover all forms of medical
equipment with the intent to ensure that only				In 1998, the United States and the European
safe and effective products are sold in the				Union introduced the New Transatlantic
European market. The directives clearly				Agreement (NTA) to improve economic
outline regulations regarding manufacturing,				cooperation between the two economic powers.
importing, and marketing of such devices. The				In this landmark accord resides the Mutual
IVDD specifically involves in vitro ( in an				Recognition Agreement (MRA) that acknowledges
artificial environment outside the living				the regulatory standards of the respective
organism ) medical devices that examine human				economic bodies-an area of transition that
fluids or tissue samples to identify,				affects the medical device industry. The
diagnose, and monitor medical conditions. The				European Union medical device directives
IVDD 98/79/EC brings in vitro devices in line				refer to ISO 9001 as the series of quality
with other medical devices already regulated				management standards and the US refers to
by the EU, the MDD (Medical Devices				FDA's Quality System Requirements and all
Directive) and the AIMDD (Active Implantable				corresponding good manufacturing (GMP)
Medical Devices Directive).The IVDD and it				practices regulations. Benefiting medical and
sibling directives apply progressive				pharmaceutical companies, both quality
regulatory requirements to medical devices				systems have made considerable efforts to
and their accessories depending on the				synchronize their requirements further
classified risk they present to the user,				increasing the common ground between quality
defined in the directive as Class I through				systems in North America and Europe.ISO
III. Unless the classified product is a				(International Organization for
low-risk Class I device that does not contain				Standardization)
any sterile packaging or a measuring
function, manufacturers require a third-party				Adding to the pressure the current ISO
Notified Body to independently certify the				9000:1994 standard is transitioning to a new
device's compliance to the Directive's				ISO: 9000:2000 series effective December 14th
Essential Requirements (a.k.a. Annex I)-good				of this year. However, as of May 15, 2003,
faith is not enough. Additionally, in a new				only 19.5% of the total ISO registered North
twist within the Directive, the authorized				American companies had completed their
representative shown on the device label for				registration process. This is essential in
Class I devices manufactured outside the EU				the entire chain of requirements. The new
may be required to produce the technical				standard is a consolidation of ISO 9001 and
file, including copies of all translated				9002, and has more of a customer satisfaction
materials. Any incorrect labeling or				and continuous improvement focus not present
instructions for use may lead to regulatory				in previous versions.GMP (Good Manufacturing
criminal or product/civil liability in the				Practices)
EU.Any medical device manufacturer wishing to
market its products in the European Union is				In December 1978, the FDA Good Manufacturing
fully responsible for complying with the				Practices (GMP) Regulation became effective,
corresponding safety and administrative				establishing Quality System Requirements for
Essential Requirements and must display the				products regulated under the FDA, including
CE mark of conformity as stated in Article 16				medical devices. In 1990, the Safe Medical
of the IVDD 98/79/EC . If that's not a red				Devices Act (SMDA) expanded the GMP to
flag, consider the next regulatory deadline				include design, manufacturing, packaging,
facing in vitro device manufacturers: By				labeling, storage, installation and servicing
December 7, 2005, the European Union will not				of all finished medical devices.Exporting
only require a CE mark to legally market a				American Medical Devices
product, but will require a CE mark to
legally put a medical device into service-a				Any medical device in the US market may not
requirement much more critical to the revenue				be legally exported anywhere in the world
of manufacturers and healthcare!CE Mark: A				without prior FDA notification or approval;
passport to the European Union				however, for a device to be legally
				distributed in the US, the FDA requires:
An abbreviation of a French phase
"Conformite Europeene," the CE mark indicates				Registration of both the medical device and
that the medical device manufacturer has				manufacturing site- Authorization for
conformed to all the obligations set forth by				commercial distribution through either a
the Directive 98/79/EC of the European				510(k) pre-market notification or a
Parliament. Affixing this multinational				Pre-market Approval (PMA) application
standardized mark to a product will allow any				depending upon the classification of the
global manufacturer a "passport" to freely				device- Compliance with FDA labeling
distribute their products within the European				requirements- Manufacturing compliance with
Union without additional quality testing or				the FDA's GoodManufacturing Practices
approvals. Reflective of the 1946 Treaty of				(GMP)While the FDA does not place any
Rome, the CE mark is a conformity tool that				restrictions on the export of these devices,
is intended to further promote the				certain countries require an Export
establishment of a single market where the				Certificate that the manufacturer and its
free movement of goods, persons, services and				devices are indeed in compliance with FDA
capital are ensured. Fundamentally, the CE				regulations. Medical devices that do not have
mark and the medical device directives remove				a 510(k), PMA, or are solely manufactured for
many regulatory hurdles while providing				export may by approved for exportation by the
stronger regulations for smaller countries;				FDA through Section 801(e)(1) of the FFDCA;
however, it also creates critical language				however, the manufacturer may experience
compliance issues that may prove to be costly				regulatory difficulties depending on the
for manufacturers. Regardless of the intended				individual country's requirements of an FDA
global harmonization, participating countries				Export Certificate, which, as stated above,
are preserving their national cultures and				require a 510 (k) or a PMA.Sorting through
languages by requiring product information in				the regulations to achieve global product
their own local languages.IVDD, MDD &				delivery
AIMD...more languages!
				The question facing medical device
Depending on device classification, to				manufacturers in the current global market is
legally display the CE mark, the IVDD, MDD,				how to meet all language requirements in the
and AIMD all mandate that manufacturers				most cost-effective, regulatory compliant
provide all labeling, information for usage,				manner. Managing regulations and translations
documentation, and marketing materials in the				are among the most critical aspects of
official language(s) of the end-user's Member				developing and marketing products for the
State, taking into account the training and				life sciences industries. Any mistake, no
knowledge of the potential users as stated in				matter how minor, can delay product
Article 4, Paragraph 4, IVDD 98/79/EC				approvals, launches, or cause widespread
.Documentation Translation Requirements -				public relations disasters. Therefore,
Conformity Assessment Procedures				developing translation and localization
				processes has become a competitive advantage
Manufacturers are required to translate the				for global manufacturers of medical
documentation relating to the production,				devices.Working closely with a translation
testing and quality processes in the official				and localization vendor who specializes in
language(s) of the Member State in which the				medical language services is an important
procedures are carried out as stated in				step in conquering the ever-changing
Article 9, Paragraph 11 of the IVDD 98/79/EC.				international regulatory process. The choice
Depending on device classification, these				of the translation provider is extremely
documents must include a number of required				important to ensure that translations are
disclosures dependent on the product				accurate, consistent and technically correct,
classification.				as well as harmonious with the manufacturers'
				processes.Medical language service providers
Depending on marketing and distribution				should-at the very least-provide documented
objectives, some products may require up to				processes that involve native-speaking
12 languages, creating complicated				linguists that have expertise in both medical
multilingual product labeling and IFU				translation and the medical industry. To
challenges. There can be over 20 information				deliver consistency, quality and reduced
pieces required for each product label of				costs, the language service provider should
IFU, depending on the classification as				also implement terminology management tools
detailed in Annex I, Part B, Section 8 of the				and computer-assisted translation solutions
Directive.Table I				in concert with the team of human
				translators.Conclusion
Official Language(s) of EU Member
StatesMember State Official				Complex and ever-changing international
language(s)Austria - GermanBelgium -				regulations controlling the marketing and
Dutch, French & GermanDenmark -				usage of medical devices are forcing
DanishFinland - FinnishFrance -				manufacturers to incorporate language
FrenchGermany - GermanGreece -				translation and localization into global
GreekIreland - EnglishItaly -				development strategies. The European Union
ItalianLuxembourg - French, German,				members currently require that all product
LuxembourgishNetherlands - DutchPortugal				information be in the official language of
- PortugueseSpain -				the local users and the diversity of this
SpanishSweden - SwedishUnited				economic area is only growing to include more
Kingdom - EnglishTable II				regulations and official languages. A
				simultaneous global release of medical
Official Language(s) of EFTA Member States				devices involving up to 12 languages in
				Europe alone makes this issue as critical as
Member State Official language(s)Iceland -				the intended purpose of the medical device.
IcelandicLiechtenstein - GermanNorway
- NorwegianSwitzerland - German,				Medical device manufacturers can
French & Italian( Switzerland is not a EFTA				cost-effectively market their products
member but requires translation)Table III				globally while satisfying international
				regulatory requirements by partnering with
Official Language(s) of Member States				Net-Translators a qualified language service
Applying For EU Membership				provider in the very early stages of product
				development. The right language partner can
Member State Official language(s) Bulgaria				turn what may now appear as a chaos of
- BulgarianCyprus - GreekCzech				regulatory requirements into a successful
Republic - CzechEstonia -				international product release.
EstonianHungary - HungarianLatvia

1 A B C D 58 59 60 61 62 63 64 66 67 68 69 70 71 72 74 75 76 77 78 79 80 81 84 85 87 88 89 91 92 94 95 96 97 98 99 100 101 102 103 104 106 107 108 109 110

How health care system works

European Regulatory Language Requirements